Improving Memory in Patients With Multiple Sclerosis

This study has been withdrawn prior to enrollment.
(Study terminated/withdrawn)
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00062972
First received: June 18, 2003
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

People with multiple sclerosis (MS) suffer from cognitive and other brain problems. This study will examine the effectiveness of the drug donepezil and of sugar water for enhancing memory in individuals with MS. Donepezil (also known as Aricept) has been FDA approved for improving memory and learning in individuals with Alzheimer's disease.


Condition Intervention Phase
Multiple Sclerosis
Drug: donepezil
Drug: glucose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Interventions to Improve Memory in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 60
Study Start Date: September 1999
Estimated Study Completion Date: August 2002
Detailed Description:

Cognitive dysfunction is one of the leading causes of disability in people with MS. Memory involving specific words (verbal memory) is particularly affected in individuals with MS. Attempts to rehabilitate cognitive dysfunction in MS have had only limited success.

This study will determine the efficacy of donepezil therapy and glucose administration for enhancing verbal memory functioning in individuals with MS. The study will also measure secondary outcomes assessing other areas of cognitive dysfunction (i.e., nonverbal memory, conceptual thinking, processing speed) which may improve with intervention.

Forty participants with MS will be randomly assigned to receive either donepezil or placebo for 24 weeks. Participants will complete memory and cognitive tests at the beginning and end of the 24 week period.

Twenty participants with MS will be randomly assigned to drink a beverage sweetened with either glucose or saccharin (placebo). Participants will then complete memory and other cognitive tests. Two weeks later, participants will drink a beverage sweetened with the alternative sweetener and again complete the memory and cognitive tests.

  Eligibility

Ages Eligible for Study:   18 Years to 56 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • MS as defined by the Poser criteria
  • Expanded Disability Status Scale (EDSS) score of 0 to 6.5
  • Stable neurologic function for at least 30 days prior to study entry
  • Agree to continue all current medications for study duration
  • Rey Auditory Verbal Learning Test score in low normal range or below
  • Mini-mental status exam score of 26 or higher
  • Montgomery-Asberg Depression Scale scaled score of 14 or lower
  • Fluent in English

Exclusion Criteria

  • Use of anticholinergic or benzodiazepine medication
  • Change in dosage of medications judged to have the potential to impact cognitive function (e.g., antispasticity medications) within 2 weeks of study entry
  • Current alcohol or substance abuse
  • History of neurological or major medical problem that has a known effect on cognitive functioning
  • History of noncompliance
  • Visual or upper extremity impairment which precludes ability to participate in cognitive assessment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062972

Locations
United States, New York
University Hospital and Medical Center
Stony Brook, New York, United States, 11794-8121
Sponsors and Collaborators
U.S. Department of Education
Investigators
Principal Investigator: Lauren B. Krupp, MD Department of Neurology, University Hospital Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00062972     History of Changes
Other Study ID Numbers: 1R01 HD38107-01
Study First Received: June 18, 2003
Last Updated: May 20, 2011
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Multiple Sclerosis
Cognitive Dysfunction
Treatment Interventions
Verbal memory deficits

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014